Implant Breast ReconstructionNCT04245930
Bovine Pericardial Patch and TiLOOP® Bra Mesh in Immediate Implant Breast Reconstruction.
A study testing Bovine Pericardial Patch in Immediate Implant Breast Reconstruction and TiLOOP® Bra Mesh in Immediate Implant Breast Reconstruction in people with Implant Breast Reconstruction and TiLOOP® Bra Mesh, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This study is the first randomized and controlled study assessing the efficacy and safety of bovine pericardial patch and TiLOOP® bra mesh in patients with immediate implant breast reconstruction Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Implant Breast Reconstruction, TiLOOP® Bra Mesh, Bovine Pericardial Patch
- What is being tested?
- Bovine Pericardial Patch in Immediate Implant Breast Reconstruction and TiLOOP® Bra Mesh in Immediate Implant Breast Reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with I~II stage breast cancer and Intent to receive NSM or SSM and implant based breast reconstruction
- Do not smoking in the last 4 weeks or more
- Mental health patients
- Signed consent to participate
Who cannot join
- Locally advanced stage patients or patients with distal metastasis
- Patients received thoracic wall radiotherapy or will receive radiotherapy
- Smoking in the last 4 weeks
- Anticipated implant volume more than 600cc
- Patients of pregnancy or lactation
- Patients received neoadjuvant therapy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
Chunyong Han, MD., +86-22-23340123 ext. 1174, hancy_007@126.com
Jian Yin, MD.
About this study
Official title: A Randomized and Controlled Study of Efficacy and Safety of Bovine Pericardial Patch and TiLOOP® Bra Mesh in Patients With Immediate Implant Breast Reconstruction.
This study is the first randomized and controlled study assessing the efficacy and safety of bovine pericardial patch and TiLOOP® bra mesh in patients with immediate implant breast reconstruction
- Being tested
- Bovine Pericardial Patch in Immediate Implant Breast Reconstruction, TiLOOP® Bra Mesh in Immediate Implant Breast Reconstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bovine Pericardial Patch in Immediate Implant Breast ReconstructionProcedure or surgery
Patients will receive immediate breast implant reconstruction using Bovine Pericardial Patch
TiLOOP® Bra Mesh in Immediate Implant Breast ReconstructionProcedure or surgery
Patients will receive immediate breast implant reconstruction using TiLOOP® Bra Mesh
| Study group | Role | What they receive |
|---|---|---|
| Bovine Pericardial Patch | Active comparator | Immediate implant breast reconstruction using bovine pericardial patch. n=88 Receives: Procedure: Bovine Pericardial Patch in Immediate Implant Breast Reconstruction |
| TiLOOP® Bra Mesh | Experimental | Immediate implant breast reconstruction using TiLOOP® Bra Mesh. n=88 Receives: Procedure: TiLOOP® Bra Mesh in Immediate Implant Breast Reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication Rates
The rate of complications in the two groups
Measured: up to 12 months after surgery
Secondary outcomes (4)
Patient satisfaction-Breast-Q questionnaire
We use the Breast-Q questionnaire to evaluate patients' satisfaction via the reconstruction module of BREAST-Q.
Measured: up to 12 months after surgery
Cosmetic outcome of reconstructed breast
Harris evaluation score was used to evaluate the aesthetic outcome of patients' reconstructed breasts, which was scored as "excellent," "good," "fair," "poor".
Measured: Immediately, up to 3 months, 6 months and 12 months after surgery
The rate of surgical revision of reconstructed breasts
To record the rate of surgical revision events of the reconstructed breasts
Measured: up to 12 months after surgery
Health economics-inpatient cost
Hospital inpatient costs due to immediate implant breast reconstruction
Measured: up to 12 months after surgery, including the cost of surgical revision
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2020
- Study start1 Jan 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant Breast ReconstructionStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jian Yin, MD., Principal investigator, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04245930
- Sponsor's protocol ID
- E2019453
- Status last verified
- Jan 2020
- First submitted
- 28 Jan 2020
- Last updated
- 5 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized and Controlled Study of Efficacy and Safety of Bovine Pericardial Patch and TiLOOP® Bra Mesh in Patients With Immediate Implant Breast Reconstruction.
- ClinicalTrials.gov ID
- NCT04245930
- Acronym / sponsor ID
- E2019453
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 29 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is the first randomized and controlled study assessing the efficacy and safety of bovine pericardial patch and TiLOOP® bra mesh in patients with immediate implant breast reconstruction
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bovine Pericardial Patch | Active comparator | Procedure: Bovine Pericardial Patch in Immediate Implant Breast ReconstructionImmediate implant breast reconstruction using bovine pericardial patch. n=88 |
| TiLOOP® Bra Mesh | Experimental | Procedure: TiLOOP® Bra Mesh in Immediate Implant Breast ReconstructionImmediate implant breast reconstruction using TiLOOP® Bra Mesh. n=88 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients diagnosed with I~II stage breast cancer and Intent to receive NSM or SSM and implant based breast reconstruction
- Do not smoking in the last 4 weeks or more
- Mental health patients
- Signed consent to participate
Key exclusion criteria (6 listed)
- Locally advanced stage patients or patients with distal metastasis
- Patients received thoracic wall radiotherapy or will receive radiotherapy
- Smoking in the last 4 weeks
- Anticipated implant volume more than 600cc
- Patients of pregnancy or lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bovine Pericardial Patch in Immediate Implant Breast ReconstructionPatients will receive immediate breast implant reconstruction using Bovine Pericardial Patch | Procedure or surgery | Bovine Pericardial Patch |
| TiLOOP® Bra Mesh in Immediate Implant Breast ReconstructionPatients will receive immediate breast implant reconstruction using TiLOOP® Bra Mesh | Procedure or surgery | TiLOOP® Bra Mesh |
Primary outcome
Complication Rates
Time frame: up to 12 months after surgery
The rate of complications in the two groups
4 secondary outcomes
Patient satisfaction-Breast-Q questionnaire
Time frame: up to 12 months after surgery
Cosmetic outcome of reconstructed breast
Time frame: Immediately, up to 3 months, 6 months and 12 months after surgery
The rate of surgical revision of reconstructed breasts
Time frame: up to 12 months after surgery
Health economics-inpatient cost
Time frame: up to 12 months after surgery, including the cost of surgical revision
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jian Yin, MD. principal investigator
Tianjin Medical University Cancer Institute and Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bovine Pericardial Patch in Immediate Implant Breast Reconstruction and TiLOOP® Bra Mesh in Immediate Implant Breast Reconstruction in people with Implant Breast Reconstruction and TiLOOP® Bra Mesh, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chunyong Han, MD. (+86-22-23340123 ext. 1174, hancy_007@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complication Rates (time frame: up to 12 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.